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Trial Title: 177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study

NCT ID: NCT05496959

Condition: Oligometastatic Prostate Carcinoma
Prostate Adenocarcinoma
Recurrent Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8

Conditions: Official terms:
Prostatic Neoplasms
Adenocarcinoma

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Lutetium Lu-177 PNT2002
Description: Given IV
Arm group label: Arm 2 (177Lu-PNT2002, SBRT)

Other name: 177Lu-labeled PNT2002

Other name: 177Lu-PNT2002

Other name: [Lu-177]-PNT2002

Other name: [Lu-177]-PSMA-I and T

Other name: Lu177-PNT2002

Other name: Lutetium Lu-177-PNT2002

Intervention type: Other
Intervention name: Quality-of-Life Assessment
Description: Ancillary studies
Arm group label: Arm 1 (SBRT)
Arm group label: Arm 2 (177Lu-PNT2002, SBRT)

Other name: Quality of Life Assessment

Intervention type: Radiation
Intervention name: Stereotactic Body Radiation Therapy
Description: Undergo SBRT
Arm group label: Arm 1 (SBRT)
Arm group label: Arm 2 (177Lu-PNT2002, SBRT)

Other name: SABR

Other name: SBRT

Other name: Stereotactic Ablative Body Radiation Therapy

Summary: This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.

Detailed description: PRIMARY OBJECTIVE: I. To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) versus SBRT plus neoadjuvant lutetium Lu-177 PNT2002 (177Lu-PNT2002), with progression defined on the basis of prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT) scans obtained at standard intervals (12 months and 24 months post-SBRT) or at the time of prostate-specific antigen (PSA)-based biochemical progression, or initiation of salvage therapy or death. SECONDARY OBJECTIVES: I. To evaluate disease burden of disease (including local control of irradiated lesions and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease who have not progressed by that point. II. To assess physician-scored toxicity (Common Terminology Criteria for Adverse Events version 5.0 [CTCAE v 5.0]) of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease. III. To assess patient-reported quality of life (based on the brief pain inventory scale) after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease. IV. To assess androgen deprivation therapy (ADT)-free survival after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease. V. To determine local control of irradiated lesion at 12 months after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease (based on a scheduled PSMA-PET). VI. To assess time to locoregional progression, time to distant progression, time to new metastasis, and duration of response after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease (based on standard of care imaging). CORRELATIVE OBJECTIVES: I. To enumerate circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic acid (ctDNA) at baseline, 3 months, 6 months, and 12 months after SBRT. II. To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood monocytes at baseline, 3 months, 6 months, and 12 months after SBRT. III. To perform radiomics analysis on PSMA PET/CT scans performed at +12 months (mo.), +24 months post-SBRT, or at time of progression. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive 177Lu-PNT2002 intravenously (IV) over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment patients are followed up at 1, 3, 6, 9, and 12 months, then every 6 months until 60 months of total follow-up.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - No indication for urgent or emergent radiation - Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable) - White blood cell count >= 2.5 × 10^9/L - Platelets >= 100 × 10^9/L - Hemoglobin >= 9 g/dL - Total bilirubin =< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN if known history of Gilbert's syndrome - Alanine aminotransferase or aspartate aminotransferase =< 3.0 × ULN or =< 5.0 × ULN for patients with liver metastases - Serum creatinine =< 1.5 × ULN or creatinine clearance >= 50 mL/min - Serum albumin > 3.0 g/dL - Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration - Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: - Patients with neuroendocrine or small cell carcinoma of the prostate - Patients with castrate-resistant disease (i.e., PSA > 0.5 ng/mL with serum testosterone < 150 ng/dL) - Patients who received androgen deprivation therapy within 6 months of trial enrollment - Concurrent systemic therapy for a solid organ malignancy - Spinal cord compression - Inability to lie flat - Known hypersensitivity to components of 177Lu-PNT2002 - Serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min - Total bilirubin > 1.5 × ULN or > 3.0 × ULN if known history of Gilbert's syndrome - Alanine aminotransferase or aspartate aminotransferase > 3 × ULN (or 5 × ULN for patients with known liver metastases) - De novo oligometastatic disease

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UCLA / Jonsson Comprehensive Cancer Center

Address:
City: Los Angeles
Zip: 90095
Country: United States

Start date: September 2, 2022

Completion date: September 1, 2033

Lead sponsor:
Agency: Jonsson Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Agency class: Industry

Source: Jonsson Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05496959

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